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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The US Food and Drug Administration (FDA) announced it is amending its regulations to correctly reference the statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a banned device.

The correction of the error, which is taking effect immediately, will further align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause, FDA says.

FDA spokeswoman Deborah Kotz told Focus: “The Safe Medical Devices Act (SMDA) passed by Congress in 1990 amended the Federal Food, Drug and Cosmetic Act to narrow the requirement regarding when FDA must offer informal hearings from one that required FDA to offer an informal hearing for all proposed bans to one that only requires FDA to offer one for proposed bans with a special effective date.

“FDA’s device ban regulations at 21 CFR part 895 have been amended to reflect this change. The technical amendment that published yesterday corrects an error in 21 CFR part 16 in the lists of statutory and regulatory provisions that require informal hearings to be offered so that these lists reference the correct statutory and regulatory provisions pertaining to device bans,” she added.

The change will not have any impact on the availability of informal hearings.

“FDA decided to make these changes because a stakeholder recently brought the inconsistency to our attention,” Kotz explained. “However, these changes only update a list of citations; they do not add or detract from hearing availability, which was altered in 1990 under SMDA.”